Report shows how the FDA incorporates the two ISO standards in its medical device development policy, how the EU version of the two standards differs in significant ways and how the EU Medical Device Regulation may require further changes in the European standards.

NOVELOS AND FDA AGREE TO LUNG CANCER TRIAL DESIGN

After undergoing a special protocol assessment with the FDA, Novelos Therapeutics is set to begin a pivotal Phase III trial evaluating its lead product NOV-002 in combination with first-line chemotherapy in the treatment of advanced non-small cell lung cancer.

The randomized, open-label, international trial will evaluate NOV-002 in combination with paclitaxel and carboplatin versus paclitaxel and carboplatin alone, in 840 patients with Stage IIIb/IV NSCLC.